Committee Insights | 7.26.23 | Concepts for Regulatory Consideration – Shifting the Conversation from “Cannabis vs. Hemp” to “The Cannabinoids”
NCIA’s #IndustryEssentials webinar series is our premier digital educational platform featuring a variety of interactive programs allowing us to provide you timely, engaging and essential education when you need it most.
In this edition of our NCIA Committee Insights series, originally aired on July 26, we were joined by leading cannabinoid product manufacturers and Cannabis Regulators Association (representing cannabis and hemp regulators across more than 40 states and U.S. territories) to examine different approaches to regulating consumer products containing cannabinoids across the US and discuss the potential for harmonized regulations in the future.
Regulating the cannabinoids is difficult enough, but throw in the challenges associated with cannabinoids derived from marijuana or hemp and the challenges can get even more complicated. Not to mention the debate between intoxicating and non-intoxicating cannabinoids and how to address the risks to public health and safety from these different types of cannabinoids. Then you have the proverbial “cherry on top” with how to address cannabinoids, both naturally occurring and novel, being produced by genetically modified organisms and scientists in the lab. There has got to be a logical way to solve this problem.
One potential solution is shifting the conversation away from cannabis vs. hemp and toward the constituents of concern, the cannabinoids. By regulating the cannabinoids, we can focus the debate on what matters, how to regulate cannabinoid ingredients in a way that is proportional to the level of risk to public health and safety. This ensures we have both a functional and vibrant cannabinoid products market and the means to protect consumers.
Learning Objectives:
• Learn about the similarities and differences between marijuana and hemp regulations for consumer products containing cannabinoids
• Find out what a consumer product containing cannabinoids is and how this concept can be used to promote more common sense regulations
• Listen to new perspectives on the challenges facing the cannabinoid-containing consumer products space and how to more efficiently regulate this marketplace
Curious about the complex world of cannabinoid regulation? Sit back and settle in for an insightful webinar where we delve into the challenges (and solutions!) surrounding cannabinoids derived from marijuana and hemp.
Safeguarding Consumers in the Cannabinoid Product Landscape (Part III):
Know Your Hazards – Occupational Health and Safety Considerations in Cannabinoid Ingredient Manufacturing (Part IV): https://bit.ly/3rEUeKP
Committee Insights | Safeguarding Consumers in the Cannabinoid Product Landscape
NCIA’s #IndustryEssentials webinar series is our premier digital educational platform featuring a variety of interactive programs allowing us to provide you timely, engaging and essential education when you need it most.
In this edition of our NCIA Committee Insights series, originally aired on June 13, we were joined by members of NCIA’s Cannabis Manufacturing, Scientific Advisory and Hemp Committees for an in-depth discussion of the current cannabinoid testing & labeling landscape alongside complications compounding consumer safety and product manufacturing concerns.
Consumer products that contain cannabinoids are a popular new consumer product category sweeping the United States. Whether these consumer products are manufactured using cannabinoids derived from cannabis or hemp, consumers deserve to know what they are consuming.
Truth in labeling is critical to providing cannabinoid content information to a consumer so they can make an informed purchase decision and in ensuring consumer safety. However, with so many different label content requirements from state to state for consumer products containing cannabinoids, this lack of consistency can lead to potential risks to the end consumer.
This is especially true when the majority of cannabinoid product manufacturers are dependent on third-party data during product manufacturing and compliance testing. This interdependence between testing laboratories and product manufacturers makes it all the more important that label content requirements are both achievable from a manufacturing standpoint without being overly burdensome for regulators to verify and do not endanger public health and safety.
In this webinar, our panelists explored about the current state of America’s somewhat-monitored cannabinoid-product marketplace, and examined several of the issues related to cannabinoid quantification, cannabinoid content declarations, and label claim verification and how these relate to consumer safety.
Learning Objectives:
• Learn about the potential risks associated with untested, unlabeled products both for the business owner and as a consumer
• Review the current landscape of cannabinoid testing requirements, how they vary state to state and the role 3rd party labs play in the picture
• Understand the nuances with label content compliance and implications on label claims
• Explore data integrity issues preventing consumers from making informed decisions
• Share best practices for what the the industry should do, what consumers can do and what regulators need to do
Panelists:
Paul Coble
Technology Attorney
Harris Bricken Sliwoski LLP
Matthew Johnson
Vice President, Risk Services
QuadScore Insurance Services
Safeguarding Consumers in the Cannabinoid Product Landscape (Part III): https://bit.ly/3Xc9Lx6
Know Your Hazards – Occupational Health and Safety Considerations in Cannabinoid Ingredient Manufacturing (Part IV): https://bit.ly/3rEUeKP
Concepts for Regulatory Consideration – Shifting the Conversation from “Cannabis vs. Hemp” to “The Cannabinoids” (Part V): https://bit.ly/3P3r5AW
Committee Blog: A Novel Cannabinoid Conundrum – Loopholes, Liability, and Legislation
by Matthew Johnson and Doug Esposito members of NCIA’s Risk Management and Insurance Committee
For better or for worse, the cannabis industry is easily the most fascinating experiment in state regulation that this country has ever seen.
Rules vary widely from state to state.
Product testing requirements lack uniformity.
Packaging and labeling are a compliance nightmare.
State laws aren’t the only things that vary, though…
Product Liability definitions of what is even ‘covered’ by a cannabis insurance policy range widely between insurance companies. Now, a tidal wave of novel cannabinoid products threatens to upend the traditional American perception of cannabis – and possibly teach a few lackadaisical insurers an expensive lesson.
So, let’s delve into the issues associated with product liability and novel cannabinoids in the American cannabis industry…
American cannabis companies face a daunting task when it comes to navigating the complex and constantly evolving landscape of regulations governing the production, distribution, and sale of cannabis products. With 40 sets of rules governing different state markets, plus a handful of federally licensed businesses, ensuring compliance can seem like an insurmountable challenge.
One of the most significant issues facing cannabis companies is product liability, including the ongoing blight of product recalls. As with any consumer product, there is a risk of harm associated with the usage of cannabis products – things like adverse reactions, contamination, mislabeling, or improper dosage, to name a few. The legal and financial implications of product liability can be severe, including lawsuits, fines, and irreversible reputational damage. Given the complexity of the state-segregated cannabis supply chains and the lack of clear federal guidance, it is additionally challenging for companies to identify and mitigate potential risks.
Traditional cannabis companies must also contend with the emergence of novel cannabinoids. As researchers continue to explore the potential therapeutic benefits of cannabis, previously unknown cannabinoids are being discovered and brought into the mainstream. These compounds may have unique properties and potential therapeutic applications, but they also pose challenges in terms of safety and regulation. For example, some novel cannabinoids may be more potent or have different effects than traditional cannabinoids like THC and CBD. What’s worse, some novel cannabinoid products can even produce substances that are deleterious to human health (for example – the vaporization of THC-O Acetate produces toxic ketene gas).
The challenges associated with product liability and novel cannabinoids highlight the need for clear and consistent regulation of the cannabis and hemp industry. While some states have taken steps to create comprehensive regulatory frameworks for cannabis, the lack of federal guidance has created an incoherent patchwork of rules and regulations that can be difficult for even the most seasoned minds in compliance to navigate.
Without sensible and congruous regulations, companies may be forced to operate in a legal gray area, increasing the risk of non-compliance and potential harm to consumers. In fact, this is exactly what’s happening with the unregulated intoxicating cannabinoid market. A veritable alphabet soup of novel intoxicants like Delta-8 THC, THCP, THC-O Acetate, and others have sprung up to fill the gap in access perpetuated by the federal illegality of ‘normal’ marijuana products. Beyond that, some folks are synthesizing Delta-9 THC (the ‘normal’ THC molecule) from hemp and marketing it as if it were naturally occurring THC from marijuana.
These products are increasingly problematic for cannabis consumers. While intoxicating hemp-derived products are technically legal through a loophole in the Farm Bill, states have had to take action to ban or regulate novel cannabinoid products. The states that haven’t acted are effectively endorsing the sale of untested cannabis goods often derived from federally legal hemp. This means that novel cannabinoid products get a free pass in many areas for heavy metals, mycotoxins, pesticides, residual chemicals, and other contaminants that the regulated marijuana industry must monitor to maintain good standing with a state cannabis program.
As if varying state regulations weren’t enough, insurers’ definitions of what is considered ‘cannabis’ vary widely too. Some policy forms contemplate hemp-derived cannabinoids as ‘cannabis’ and some do not.
A few examples of policy wording are below:
Carrier A:
“Medical Marijuana means cannabis or marijuana, including constituents of cannabis, THC, and other cannabinoids, as a physician-recommended form of medicine or herbal therapy”
Carrier B:
Simple exclusion for ‘Hemp-Derived Intoxicating Cannabinoids’
Carrier C:
“Cannabis” means:
Any good or product that consists of or contains any amount of Tetrahydrocannabinol (THC) or any other cannabinoid, regardless of whether any such THC or cannabinoid is natural or synthetic.
The paragraph above includes, but is not limited to, any of the following containing such THC or cannabinoid:
(1) any plant of the genus Cannabis, or any part thereof, such as seeds, stems, flowers, stalks and roots; or
(2) any compound, byproduct, extract, derivative, mixture or combination, such as, but not limited to:
(a) Resin, oil or wax;
(b) Hash or hemp; or
(c) Infused liquid or edible marijuana;
Whether or not derived from any plant or part of any plant set forth in the paragraph above.
From the get-go, you can infer a few things from these definitions/exclusions:
Carrier A: not an adult-use cannabis company’s best choice as it only defines ‘medical marijuana.’ This could leave the door open for potentially uncovered claims from recreational products.
Carrier B: insurance company is looking to protect itself from issues with the new wave of novel cannabinoid products – but specifically, only the dozen or so intoxicating cannabinoids that can legally be synthesized from hemp (without testing mandates in most states). An important takeaway is that this definition would cover non-intoxicating cannabinoids like CBN or CBC, even if they were derived from hemp.
Carrier C: this language is/was commonly used across a number of insurance carriers who cover cannabis. Their policies may carry some restrictions, but this broad definition of cannabis includes synthetic cannabinoids and could expose the carrier to major lawsuits.
Those with broader definitions that include all cannabis-derived products often restrict their product liability coverage in other ways. All things considered, the industry has a long way to go until the available product liability coverage can truly be called comprehensive.
To address these challenges, policymakers, industry leaders, and consumers must work together to create a regulatory framework that protects public health and safety while supporting the growth of the cannabis industry. This should include clear guidelines for product labeling, testing, and dosing to ensure that consumers have access to safe and accurately labeled cannabis products. It should also include provisions for product recalls and liability to protect consumers in the event of unexpected quality control issues.
Additionally, the framework should support ongoing research into the therapeutic potential of cannabis, including novel cannabinoids. This research should be conducted in a manner that ensures the safety and efficacy of new compounds before they are introduced to the market. By creating a robust regulatory framework that balances innovation with consumer protection, we can ensure that the cannabis industry continues to grow and evolve in a responsible and sustainable manner.
As risk professionals in this field, it’s our duty to convey the urgency of these issues and the need for action. By working together to create a regulatory framework that supports both innovation and consumer protection, we can ensure that the cannabis industry continues to thrive while safeguarding public health and safety.
It’s time for policymakers, industry leaders, and consumers to come together to address these critical challenges and build a sustainable future for the American cannabis marketplace that is inclusive of all the various products that can be developed from cannabis.
Matt Johnson leads the Risk Services division for QuadScore, the nation’s leading cannabis insurer. Matt works to keep the cannabis industry safe from unexpected losses through all manner of risk mitigation techniques, ranging from facility security assessments to fire protection improvements.
Matt has the unique ability to study the claims activity for hundreds of cannabis operators across virtually every active state in the USA. Through this lens, he can offer unique insights into the most common claims and how to prevent them.
In addition to learning from past mistakes, Matt also keeps an eye on future claims drivers from emerging areas such as hemp-derived novel cannabinoids. Before starting with QuadScore, Matt spent a number of years working for a Berkshire Hathaway insurance company.
Doug Esposito has been a Property & Casualty Specialist with AssuredPartners and leads the firm’s Renewable Energy and Cannabis Practice with specific expertise in these industries. Doug’s current cannabis & hemp practice clients include indoor/outdoor cultivators, manufacturers, distribution companies, dispensaries, non-storefront delivery, labs and property owners, so he knows what challenges are facing the growing industry and is skilled at providing solutions. Doug is also one of AssuredPartner’s experts in alternative risk mechanisms including self-insured and captives programs.
Doug currently serves as the Co-Chair of the California Cannabis Industry Associations’ (CCIA) Risk Management committee and serves on the National Cannabis Industry Associations’ (NCIA) Risk Management & Insurance Committee. He understands the importance and need to educate the insurance carriers and the public on the benefits of cannabis and hemp both medicinally and economically. “I truly respect the spirit of the industry’s medicinal origins and I’m committed to helping build this industry to reach new levels of growth, success, safety and acceptance,” shared Doug.
Committee Insights | Meet the Minors (Novel, Minor, Synthetic Cannabinoids – Part II)
In this edition of our NCIA Committee Insights series, originally aired on May 11, 2023, we were joined by members of NCIA’s Cannabis Manufacturing, Scientific Advisory and Hemp Committees for an in-depth discussion of the most talked about minor, novel, and synthetic cannabinoids.
What scientific publications exist for each compound? What do we know about each molecule’s physiological, psychoactive, and therapeutic effects?
You’ll find out during this informative session featuring leading chemical experts, manufacturers and product development specialists. Along with audience members they explored these compounds from various perspectives to examine their implications for consumers, medical practitioners, patients, producers and regulators.
Learning Objectives:
• Molecular Structures and Identification of novel, minor, and synthetic compounds
• Published Physiological and Psychoactive effects of these compounds
• Perceived therapeutic effects
• Opportunity to ask about other new compounds not in presentation.
NCIA’s #IndustryEssentials webinar series is our premier digital educational series featuring a variety of interactive programs allowing us to provide you timely, engaging and essential education when you need it most.
In this edition of our NCIA Committee Insights series, originally aired on December 14 and produced in collaboration by NCIA’s Cannabis Manufacturing Committee, Scientific Advisory Committee and Hemp Committee we introduced and framed the myriad regulatory, scientific, linguistic, and ethical issues that come with the rise of minor, novel, and synthetic cannabinoids.
Learning Objectives:
• Understand the role of minor, novel, and synthetic cannabinoids in the cannabis industry and the unique issues relating to their current status.
At the conclusion of the discussion our panel hosted a lengthy moderated Q&A session so our network could get all their burning questions answered by these leading manufacturing, biochemical, and legal professionals from the hemp and cannabis industries.
Panelists:
Scott Seeley
Biochemist and Patent/TM Attorney @Eastgate IP
Cassin Coleman
Founder
Cassin Consulting
Keith Butler
CEO
OP Innovates / Hemp Mellow
Paul Coble
Intellectual Property Attorney
Harris Bricken Sliwoski LLP
There is more to cannabis than THC and CBD. As our understanding (and commercialization) of cannabis evolves, new compounds like CBG, delta-8-THC, THCv, and others are coming onto the scene. These various “minor” cannabinoids, however, bring with them a host of new issues.
Over the next few months this collaboration will continue to explore these issues with various subjects ranging from basic and advanced overviews of these molecules, regulatory recommendations, risk management and compliance concerns all the way to consumer and manufacturer safety. Stay up to date and be the first to know when additional follow-up sessions are scheduled by signing up via the form below.
From Lab to Label: Safeguarding Consumers in the Cannabinoid Product Landscape (Part III): https://bit.ly/3Xc9Lx6
Know Your Hazards – Occupational Health and Safety Considerations in Cannabinoid Ingredient Manufacturing (Part IV): https://bit.ly/3rEUeKP
Concepts for Regulatory Consideration – Shifting the Conversation from “Cannabis vs. Hemp” to “The Cannabinoids” (Part V): https://bit.ly/3P3r5AW
FDA Punts on Regulating CBD Again
by Morgan Fox, NCIA’s Director of Media Relations
Last week, the hemp and CBD industries took another blow from the Food and Drug Administration when the agency refused to grant a request from prominent CBD producer Charlotte’s Web to regulate the substance as a dietary supplement. This is the latest in a series of delays and setbacks on the part of the FDA when it comes to regulating hemp-derived cannabinoids and products since they became technically legal at the federal level under the 2018 Farm Bill.
Bloombergreports: “The company’s bid to sell its full-spectrum hemp extract with CBD as a dietary supplement won’t be considered because of the FDA’s own prior decision to treat CBD as a drug, according to a letter posted on the agency’s website Wednesday. This shouldn’t disrupt the business of Charlotte’s Web or prevent other companies from continuing to sell such products, which already exist in a gray area without the agency’s oversight. The decision shows the agency’s ongoing hesitancy to regulate cannabidiol, the non-psychoactive ingredient in cannabis plants better known as CBD… The FDA’s objection rested in part on its prior approval of Epidiolex, a CBD drug to reduce seizures, which the agency said precludes it from authorizing CBD for dietary purposes. Even if the drug hadn’t been approved, though, the FDA said in the letter to Charlotte’s Web dated July 23 that it “has concerns about the adequacy of safety evidence” that the company submitted.”
This position is likely to create serious problems for the CBD industry. Without allowing CBD products to be regulated as dietary supplements or food additives, the FDA will be forcing producers to get federal approval for their products under the Investigational New Drug program. This process can often take years and cost applicants millions of dollars.
This casts even more doubt on what the future of the CBD market will look like as producers continue to operate in an uncertain landscape. The legality of CBD combined with the lack of federal regulations has created a lot of opportunities for responsible producers to bring products to market without dealing with the often overly strict state cannabis programs, but it has also opened the door to irresponsible operators who have been accused of actions from making misleading or unsubstantiated health claims to selling mislabeled or adulterated products.
Furthermore, the lack of federal regulations has discouraged many larger retailers from selling CBD or hemp-derived products altogether, drastically limiting the market options for producers. Some industry insiders have theorized that lack of access to those retailers has directly led to some producers desperately searching for ways to unload their excess CBD, including processing it into unregulated Delta 8 THC and flooding the markets in both legal and prohibition states, creating concerns among regulators, lawmakers, licensed cannabis operators, and consumers.
This troubling news follows on the heels of another memo issued by the Farm Credit that suggests that financial institutions that provide financing to hemp businesses should only do so if the company is operating under the auspices of a USDA-approved state hemp program.
“While many states and federally recognized tribes have since submitted those plans, 20 states are still operating under an earlier provision: a hemp pilot program created by the 2014 Farm Bill. That program, which is still valid and would befurther extended under pending legislation that has passed the House and is pending in the Senate, requires less federal oversight than the new USDA-approved programs,” Marijuana Momentreports.
Some in the industry are concerned that the memo will lead to lenders dropping their hemp clients operating under the pilot programs, but others have suggested that it will not have a significant impact on the lenders who are already working with hemp businesses given the amount of reporting that they must already complete for the federal government and the lack of federal prosecutions for doing so historically.
It seems pretty clear by this point that the FDA will not move forward with regulating CBD in a timely and reasonable manner without outside pressure. You can add your voice to the chorus calling for sensible CBD regulations by visiting RegulateCBDNow and urging Congress to take action.
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